Advertisement

June 26, 2026

CroíValve Closes Financing to Enlarge TANDEM II Study of Duo System

KEY TAKEAWAYS

  • Additional financing supports expansion of CroíValve’s TANDEM II early feasibility study of the Duo tricuspid coaptation valve system.
  • The prospective United States and European Union study will expand to new clinical sites after treating the initial 15 patients.
  • The investigational Duo system is designed to treat severe symptomatic tricuspid regurgitation while preserving the native tricuspid valve anatomy.

June 26, 2026—CroíValve announced the closing of financing that will be used to fund the Ireland-based company’s expanded TANDEM II study.

The company stated that TANDEM II is a United Stated and European Union-based prospective, multicenter study evaluating the safety and performance of the CroíValve Duo tricuspid coaptation valve system in patients with severe or greater symptomatic tricuspid regurgitation (TR).

In October 2024, CroíValve announced the first patient was treated with the Duo system as part of the TANDEM II early feasibility study in the United States. With the new financing, the study is being expanded beyond the 15 patients already treated to include additional sites in the United States and European Union, stated CroíValve.

The company explained that the Duo system is a transcatheter heart valve intended to preserve the patient’s native anatomy while treating TR. It works in tandem with the native tricuspid valve to restore valve function while avoiding contact with critical structures in the right heart that could lead to complications. Duo is an investigational device that is not for sale in any geography, advised CroíValve.

As stated in the press release, the Series B expansion financing amounts to $20 million, along with $7 million grant financing from the European Innovation Council (EIC) and Ireland’s Disruptive Technologies Innovation Fund.

Additionally, the financing includes new investors, the EIC and the Business Growth Fund (BGF) of the United Kingdom, along with participation from current investors, including the Ireland-based MedTech Syndicate. Tim Rea, who is cohead of early stage investments at BGF, joined to CroíValve’s Board of Directors.

The expansion brings the total for Series B to $36 million—$43 million including grant financing, stated CroíValve.

Advertisement


June 26, 2026

Valgen’s DragonFly TMVR System Receives CE Mark Approval for FMR Indication

June 24, 2026

Corvention’s KardiaPSI Balloon Catheter Introduced in Limited Launch After FDA Clearance


)